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A Therapeutic Equivalence Study of Ketoconazole Cream 2%

NCT04203342 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2020-08-06

No results posted yet for this study

Summary

Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis.

Conditions

  • Tinea Pedis

Interventions

DRUG

Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.)

Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.

DRUG

Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)

Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.

DRUG

Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)

Topical placebo to treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • ACM Global Laboratories

    collaborator OTHER

  • Douglas Pharmaceuticals America Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2020-05-28
Completion
2020-07-13
FDA Drug
Yes

Countries

  • United States
  • Belize

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203342 on ClinicalTrials.gov